BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2113784 · Received June 2, 2011

    Report

    Report Number
    2936999-2011-00372
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER# 317-75 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K791045. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE PILOT BALLOON WOULD NOT INFLATE THE CUFF. THIS WAS DISCOVERED DURING PATIENT USE. EXTUBATION AND REINTUBATION OF REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO TRACHEAL TUBE WITH LANZ BTR COVIDIEN, FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention